In today’s blog, we will explore about US FDA 21 CFR Part 820 Quality System Regulation. Whether you’re a startup or established manufacturer, understanding the US FDA 21 CFR Part 820 Quality System Regulation is vital for ensuring regulatory compliance and bringing your product to the market

It is also important for Medical Device QA/RA Professionals to know in detail about US FDA 21 CFR Part 820 Quality System Regulation

Let’s get into the topic.

21 CFR Part 820 falls under 21 Code of Federal Regulations, Chapter 1 : Food and Drug Administration, Department of Health and Human Services, Sub Chapter H: Medical Devices.

Sub Chapter H: Medical Devices covers Part Number 800 – 898. Each part provides the requirements for different aspects of Medical Devices. Out of which 21 CFR Part 820 is specific to Quality System Regulation.

Each manufacturer must develop and maintain a quality system that is suitable for the specific medical device(s) being designed or produced, and that complies with the requirements outlined in this section.

Let’s discuss the Applicability of 21 CFR 820 and steps to be followed in case of exemptions or variances to 21 CFR 820.

Applicability of 21 CFR Part 820 Quality System Regulation

The provisions outlined in this part regulate the procedures, facilities, and controls involved in the design, production, packaging, labeling, storage, installation, and maintenance of all finished devices intended for human use. These requirements are established to ensure that the final products are both safe and effective.

This section outlines the fundamental requirements that apply to manufacturers of finished medical devices. Manufacturers involved in only specific activities covered by these requirements are obliged to comply solely with the provisions relevant to those activities. These regulations do not extend to manufacturers producing components or parts of finished devices.

The stipulations in this section apply to any finished device, as defined herein, intended for human use and manufactured, imported, or offered for import into any U.S. state or territory.

A requirement is considered “appropriate” if failing to implement it could reasonably lead to the device not meeting its defined specifications or hinder the manufacturer’s ability to perform necessary corrective actions.

Manufacturers of blood and blood components intended for transfusion or further manufacturing are not governed by this part 820 but instead fall under the regulations specified in subchapter F, “Biologics,” of this chapter.

Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in Section 1271.3(d) of this chapter, that qualify as medical devices are subject to the requirements of this part 820.

The quality system regulations in this part 820 complement other parts within this chapter, except where explicitly stated otherwise. In cases where there is a conflict between the requirements in this part 820 and those in other parts of the chapter, the specific regulations applicable to the device in question take precedence over general requirements.

Noncompliance with any applicable provision in this part renders a device adulterated under section 501(h) of the Act. Such a device, along with any individual responsible for the noncompliance, may be subject to regulatory enforcement actions.

Exemption or Variances to 21 CFR Part 820 Quality System Regulation

Anyone seeking an exemption or modification from any device quality system requirement must comply with the provisions of Section 520(f)(2) of the Federal Food, Drug, and Cosmetic Act. Such requests should be submitted following the procedures outlined in Section 10.30, “Citizen Petition,” of this chapter, which details the FDA’s administrative process.

The FDA may also initiate and approve a variance from any device quality system requirement if it determines that doing so serves the public health interest. This variance will remain valid only as long as there is a demonstrated public health need for the device and the device would likely not be sufficiently available without the variance.

In the upcoming blogs, lets discuss in detail about Sub Parts of 21 CFR 820.

Now I hope you have acquired some basic knowledge about the US FDA 21 CFR 820 Quality System Regulation. We will meet again with another valuable topic related to MedTech Quality & Regulatory, Biomedical Engineering, Medical Device, Healthcare.

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